From:
Dr. Ratn Deep Singh
Assistant Professor,
Veterinary College,
S.D.A.U., S. K. Nagar,
Dantiwada, Gujarat -385506
To,
The Editor,
International Journal of Research &
Development in Pharmacy & Life Sciences
Subject: Submission of review article for publication in IJRDPL.
Sir,
Kindly find herewith a review article entitled “Pharmaceutical Biopiracy and
Protection of Traditional Knowledge” authored by R. D. Singh et al., typed in A4 size
paper with double space, for publication in IJRDPL. I have furnished below the
information regarding complete address and e-mail ID of communicating author and
institution.
It is to be certified, on the behalf of all authors, that the article has not been
published elsewhere in any language or sent for publication in any other journal.
The authors of this article agree to all terms and conditions indicated in the
‘Instruction to Authors’.
Please acknowledge the receipt of the article and status of publication for the same.
Yours sincerely
DATE: 05-12-2013
(RATN DEEP SINGH)
Title of the review article: Pharmaceutical Biopiracy and Protection of Traditional
Knowledge.
Name and Address of the corresponding author:
Dr. Ratn Deep Singh
Assistant Professor
Department of Pharmacology & Toxicology
College of Veterinary Science & Animal Husbandry
Sardarkrushinagar Dantiwada Agricultural University
Sardarkrushinagar, Dantiwada,
District: Banaskantha
State: Gujarat (India)
Pin code – 385 506
e-mail ID: ratn1709@yahoo.com
Contact no.:- +91-96385 17179
Name and address of all the authors:
1. Ratn Deep Singh (Assistant Professor)
2. Shailesh K. Mody (Professor & Head)
3. Hitesh B. Patel (Assistant Professor)
4. Sarita Devi*(Assistant Professor)
5. Chirag M. Modi (Senior Research Fellow)
6. Divyesh R. Kamani (Postgraduate Scholar)
Address:
Department of Pharmacology & Toxicology
College of Veterinary Science & Animal Husbandry
Sardarkrushinagar Dantiwada Agricultural University
Sardarkrushinagar, Dantiwada, Banaskantha, Gujarat -385 506 (India)
* Department of Medicine
College of Veterinary Science & Animal Husbandry
Sardarkrushinagar Dantiwada Agricultural University
Sardarkrushinagar, Dantiwada, Banaskantha, Gujarat -385 506 (India)
PHARMACEUTICAL BIOPIRACY AND PROTECTION OF TRADITIONAL
KNOWLEDGE
R. D. Singh*, S.K. Mody, H. B. Patel, Sarita Devi, C.M. Modi and D.R. Kamani
Department of Pharmacology & Toxicology
College of Veterinary Science & Animal Husbandry
Sardarkrushinagar Dantiwada Agricultural University
Sardarkrushinagar, Gujarat -385 506 (India)
KEY WORDS: Traditional knowledge, Biopiracy, CBD, Nayoga Prorocol, TKDL
TRADITIONAL KNOWLEDGE
According to UNESCO definition, Traditional Knowledge (TK) is “the
cumulative and dynamic body of knowledge, know-how and representations
possessed by peoples with long histories of interaction with their natural milieu. It is
intimately tied to language, social relations, spirituality and worldview, and is
generally held collectively”. As defined by the World Intellectual Property
Organization (WIPO), it is knowledge, know-how, skills and practices that are
developed, sustained and passed on from generation to generation within a
community, often forming part of its cultural or spiritual identity
[1].
TK includes
indigenous knowledge, folklore, and traditional medical knowledge and often used to
develop commercial products such as new pharmaceuticals, herbal medicines, seeds,
cosmetics, personal care and crop protection products, e.g. traditional medicine may
be used to guide the screening of plants for medically active compounds. Knowledge
about characteristics of plants having healing properties and technology of its use
gives medicinal plants their social and economic value. This technology of use has
been acquired through thousands of years of experience, trial and error and generation
to generation refinement. As a result of this, age-old communities have developed
their knowledge of the plant, animal and mineral resources to a grown-up and
scientifically-sound technology, which reflects in old traditions of healing science like
Ayurveda and Siddha. In addition to this, tribal, island and local ethnic communities
have developed their own knowledge base about the flora, fauna and mineral wealth
of their region [2].
BIOPIRACY
Biopirates, pirates of life, are pillaging a new kind of wealth, that of
biodiversity and the traditional knowledge and techniques of rural and indigenous
peoples. Biopiracy can be defined as, “the misappropriation and commercialization of
genetic resources and traditional knowledge of rural and indigenous people”
[3].
Pharmaceutical biopiracy is a term used generally to describe the legal practice by
pharmaceutical companies exploiting the indigenous people’s traditional knowledge
of medicine. India and other developing countries are rich in bio-resources and TK are
favourite targets and victims of biopiracy. Turmeric, neem and basmati rice were well
known examples of biopiracy. Renowned economist and Nobel Prize winner Joseph
E. Stiglitz comments on the World Trade Organization’s Trade Related Aspects of
Intellectual Property Rights Agreement (TRIPS) - What we were not fully aware of
was another danger, what has come to be termed bio-piracy, international companies
patenting traditional medicines and foods. It is not only that they seek to make money
from ‘resources’ and knowledge that rightfully belongs to the developing countries,
but in so doing, they squelch domestic firms that have long provided the products [4].
Biopirates are mainly pharmaceutical, cosmetic and agri-food firms. Biopiracy of
genetic resources and genetic materials are also noticed. They draw on biodiversity
hot-spots in order to create supposedly “innovative” products and guarantee their
monopoly on them through the patent system. Such misappropriation of TK results in
grant of patent for the invention to the “first–to–file” (the pharmaceutical company)
rather than to the “first–to–invent” (the indigenous community). It involves making
profit from freely available natural products (plants, seeds, leaves etc.), by copying
techniques used daily for generations by local peoples in order to feed or take care of
themselves. Biopirates do not give any profit or proper benefit to local communities
and TK holders [3].
BIOPROSPECTING, BIOPIRACY & PHARMACEUTICAL INDUSTRY
Bio-prospecting, which usually precedes biopiracy, is the systemic search for,
and the development of, new sources of chemical compounds, genes, micro and
macro-organisms and other valuable bio-products. One of the biggest threats to
biodiversity and related traditional knowledge is ever increasingly bio-prospecting
activities on behalf of ethno-botanists, pharmaceutical companies and others who
wish to profit from the rich biodiversity and traditional knowledge in indigenous
territories [2, 5]. Bio-prospecting is the exploration of biodiversity for new biological
resources of social and economic value. It is carried out by a wide variety of
industries, the best known being the pharmaceutical industry. Research-based
industries have found it profitable to screen natural resources such as soil samples,
marine waters, insects, tropical plants and animals in developing countries. Moreover,
in recent times, enormous cost of drug development along with growing incidence of
side effects and drug-resistance has become of great concern. The search for new
molecules is, therefore, expensive, uncertain and runs the risk of huge payments in
liability when things go wrong. As compared to the conventional system of screening
millions of synthesized chemicals, TK based bio-prospecting may significantly cut
costs of pharmaceutical R&D. Hence the Pharma-industry is looking increasingly at
medicines and products that have been developed by local communities in older
cultures like India, Africa and China where the centuries-old traditions of indigenous
healing are still viable and in use. These healing practices and cures are rich hunting
grounds for biopirates.
Pharmaceutical bio-prospecting has been sharply criticized for what has
become known as ‘biopiracy’ in which large international pharmaceutical
corporations make use of local indigenous or traditional knowledge, without
acknowledging that it is indigenous intellectual property. Thus, profits have accrued
solely to the pharmaceutical companies and indigenous peoples received little or
nothing in return
[6].
The pharmaceutical industry has had a long and fruitful
relationship with biodiversity. Large pharmaceutical companies generate close to
USD 250 billion annually from drugs directly derived from biodiversity. In 2010, the
natural products mix in the pharmaceutical industry was estimated to be 40%.
Currently, 62% of cancer drugs approved by the US Food and Drug Administration
come from, or are modeled based on, natural products. In 2010, more than 40% of all
the new chemical entities were obtained from natural sources. Nearly 48% of drugs in
the clinical phase are derived from plants. Drugs currently in the pipeline that are
derived from natural sources are mostly cancer and anti-infective medicines. These
two therapeutic areas account for 56% of all drugs of natural origin in clinical trials
[7].
Collaborations between pharmaceutical companies and the countries supplying the
indigenous knowledge and medicinal resources could offer an important new revenue
source for impoverished developing countries. Therefore, efforts to establish fair and
equitable partnerships between the pharmaceutical industry and the developing
countries are imperative to ensure sustainable, mutually beneficial relationships [8].
PATENT IS MAIN TOOL FOR BIOPIRATES
Patent law, while largely influenced by western legal concepts, can differ from
nation to nation. There has been some movement towards harmonizing patent law to
satisfy the needs of many countries, but the interests of industrialized nations remain
at the forefront of patent theory. Patent law is affected by competing government
interests, but is also influenced by other entities, such as trade organizations and nongovernmental organizations (NGOs). Minimum standards for patent law exist
internationally, as evidenced by Article 27 of the Trade-Related Aspects of
Intellectual Property Rights (TRIPs) agreement. This article provides that “patents
shall be available for any inventions, whether products or processes, in all fields of
technology, provided that they are new, involve an incentive step and are capable of
industrial application. However, nations can choose to exclude certain inventions,
such as those that harm the public, types of medical treatments, and certain plants
from patentability. Individual nations have the power to interpret the terms of such
agreements in terms as broad or narrow as they wish. Agreements such as TRIPs have
been criticized as instruments used to secure enforcement of US intellectual property
rights abroad [6]. In the words of well known Indian environmental activist Vandana
Shiva, “Patents are given for an invention and a patent on life necessarily means
biopiracy.” If a patent does not respect one of the three criteria for access (novelty,
inventiveness and commercial application), it is not legally admissible and must be
canceled. Thus, a patent based on traditional knowledge is illegal, because it does not
respect the principle of novelty, nor does it respect the criteria of inventiveness [3].
INTERNATIONAL TREATIES DEALING WITH BIOPIRACY
There are two international treaties that help protect peoples and biodiversity from
biopirates:
1. Convention on Biological Diversity (CBD) evolved of the Rio Earth Summit
(1992).
2. Nagoya Protocol on biodiversity, negotiated in Japan (2010).
Before these two treaties, one earlier attempt for the protection of indigenous
knowledge (IK) or TK was made in 1994 through the United Nations Draft
Declaration on the Rights of Indigenous People. There is a clear provision in the
Declaration to recognize the ownership of the IK of the indigenous communities.
Article 29 mandates the recognition of the full ownership, control and protection of
their cultural and intellectual property. This includes human and other genetic
resources, seeds, medicines, knowledge of the properties of fauna and flora, oral
traditions, literature, designs and visual and performing arts. They are also given
rights to manage them
[2].
The International Labour Organization (ILO) also
emphasized the rights of indigenous people and the need for their recognition. The
Indigenous and Tribal Peoples Convention (Convention 169), 1989, recognized the
aspirations of these peoples to exercise control over their own institutions, ways of
life and economic development, and to maintain and develop their identities,
languages and religions within the framework of the States in which they live. The
Convention states that the rights of these peoples related to the natural resources
pertaining to their lands shall be specifically safeguarded. These rights include that of
participation in the use, management and conservation of these resources [Article
15(1)] [2].
CONVENTION ON BIOLOGICAL DIVERSITY (CBD):
In 1992, the international community designed the Convention on Biological
Diversity (CBD) as a new instrument to prevent the loss of biodiversity worldwide.
Realizing the importance of indigenous knowledge (IK) and the objective of the CBD
with regard to benefit-sharing, the Conference of Parties to the CBD, in its sixth
meeting (COP 6) in 2002, adopted the Bonn Guidelines on Access to Genetic
Resources and Fair and Equitable Sharing of the Benefits Arising out of their
Utilization. It provides the guidelines for developing legislative, administrative or
policy measures on access and benefit-sharing. Articles 15 and 8 (j) of this convention
are important and define the legal principles and criteria for bio-trade, involving the
use of natural native ingredients, and often traditional knowledge concerned. CBD
sets up three complementary objectives i.e. the conservation of biodiversity, its
sustainable use, and the fair and equitable sharing of the benefit arising from their use
which is also known as the “access and benefit sharing (ABS)” mechanism. The CBD
recognizes the value of the ‘knowledge, innovations and practices of indigenous and
local communities’ for the conservation and sustainable use of biological diversity.
The main issue is that of Access and Benefit Sharing (ABS). ABS is implemented
under Article 15 of CBD under which national governments are required to establish
domestic laws and policies to allow access to genetic resources. It aims to eradicate
the evils of biopiracy as well as protect the interests of TK holders [2, 3, 9].
NAGOYA PROTOCOL
The Nagoya Protocol on Access to Genetic Resources and the Fair and
Equitable Sharing of Benefits is a landmark treaty that was devised keeping in mind
the increasing loss of biodiversity on Earth. The Nagoya Protocol specifies the means
by which the CBD can be applied. The Nagoya Protocol, especially the ABS clause,
calls for systems to be put in place
[9].These
systems are expected to drive the costs
incurred by pharmaceutical companies during the drug discovery phase. The Nagoya
Protocol could have an adverse impact on the pharmaceutical industry. Many
companies feel that the Access and Benefit Sharing clause will increase product
development costs and complicate the drug discovery phase. According to the
protocol, organizations will have to pay a significant amount of their revenue and
royalties to indigenous communities and host countries for the drug they develop from
genetic resources. The revised patent system will also add to the cost of drug
development. Due to the rules and regulations laid down by the Nagoya Protocol,
organizations would have to execute joint patents with the communities from whom
they source resources [7].
INDIA FIGHTS AGAINST BIOPIRACY
India is one of the 17 mega-biodiversity countries with 2.4 per cent of the
global land area and accounts for 7 to 8 per cent of the recorded species of the world,
making it more prone to biopiracy [10]. The turmeric case, in which India succeeded in
overturning a patent granted by the United States Patent and Trademark Office on
turmeric powder, was a landmark in the battle against ‘bio-piracy’. It was the first
case in which a Third World country succeeded in its objection to a foreign patent on
the grounds that it was based on traditional knowledge known to the country for
generations. In 1995, two expatriate Indians at the University of Mississippi Medical
Centre (Suman K. Das and Harihar P. Cohly) were granted a US patent (no.
5,401,504) on use of turmeric in wound healing. The Council of Scientific &
Industrial Research (CSIR), India, New Delhi filed a re-examination case with the US
PTO challenging the patent on the grounds of existing of prior art. CSIR argued that
turmeric has been used for thousands of years for healing wounds and rashes and
therefore its medicinal use was not a novel invention. Their claim was supported by
documentary evidence of traditional knowledge, including ancient Sanskrit text and a
paper published in 1953 in the Journal of the Indian Medical Association. Despite an
appeal by the patent holders, the US PTO upheld the CSIR objections and cancelled
the patent. Grant of patent for fungicidal effect of neem oil in 1994 is another such
example. European Patent Office (EPO) granted a patent (No.436257) to the US
Corporation W.R. Grace Company and US Department of Agriculture for a method
for controlling fungi on plants by the aid of hydrophobic extracted Neem oil. In 1995,
a group of international NGOs and representatives of Indian farmers filed legal
opposition against the patent. They submitted evidence that the fungicidal effect of
extracts of Neem seeds had been known and used for centuries in Indian agriculture to
protect crops, and therefore, cannot be patented. In 1999, the EPO determined that
according to the evidence all features of the present claim were disclosed to the public
prior to the patent application and the patent was not considered to involve an
inventive step. The patent granted on was Neem was revoked by the EPO in May
2000 [11, 12].
Learning from such bitter experiences, Indian government framed following
acts and projects to fight against biopiracy:1. BIOLOGICAL DIVERSITY ACT (2002), INDIA
In India, enabling provisions have been made for protecting the traditional
knowledge in the Biodiversity Bill 2000. Section 36(iv) provides for protection of
knowledge of local people relating to biodiversity through measures such as
registration of such knowledge, and development of a sui generis system. For
ensuring equitable sharing of benefits arising from the use of biological resources and
associated knowledge, sections 19 and 21 stipulate prior approval of the National
Biodiversity Authority (NBA) before their access. Section 6 provides that anybody
seeking any kind of intellectual property rights on a research based upon biological
resource or knowledge obtained from India; need to obtain prior approval of the NBA.
The NBA will impose benefit-sharing conditions. Section 18(iv) stipulates that one of
the functions of NBA is to take measures to oppose the grant of IPRs in any country
outside India on any biological resource obtained from India or knowledge associated
with such biological resource. India's Biological Diversity Act, 2002 (BDA) seeks to
do several tasks, including to regulate access to biological resources with the purpose
of securing equitable share in benefits arising out of the use of biological resources
and associated TK to conserve and sustainably use biological diversity; to respect and
protect TK of local communities to secure sharing of benefits with local people as
conservers of biological resources and TK holders. The Biological Diversity Rules of
2004 further identifies benefit sharing methods such as joint ventures, technology
transfer, product development, education, awareness raising, institutional capacity
building, and venture capital funds, and states that applications will be determined on
a case by case basis [10, 13].
2. PROTECTION OF PLANT VARIETIES (PPV) AND FARMERS’ RIGHTS
ACT (2001)
The Indian legislation for the Protection of Plant Varieties and Farmers’
Rights Act, 2001, also acknowledge that the conservation, exploration, collection,
characterization, evaluation of plant genetic resources for food and agriculture are
essential to meet the goals of national food and nutritional security as also for
sustainable development of agriculture for the present and future generations [5].
3. TRADITIONAL KNOWLEDGE DIGITAL LIBRARY (TKDL)
India has taken various initiatives regarding the protection of traditional
knowledge under intellectual property rights, including the Traditional Knowledge
Digital Library (TKDL), to protect its traditional knowledge and to prevent grant of
wrong patents. A collaborative project between CSIR and Department of AYUSH,
Ministry of Health and Family Welfare, TKDL is a maiden Indian effort to help
prevent misappropriation of traditional knowledge belonging to India at International
Patent Offices. By recording the traditional knowledge, legally, it becomes public
domain knowledge. Under the patent law, this means that it is considered to be prior
art and hence is not patentable. Such a written record, in a form easily accessible to
patent offices around the world, would provide all such offices with a record of
India’s prior art. Patent examiners could easily check this database and reject any
patent application that might be a mere copy of traditional knowledge. Being in
document form, it would be acceptable to patent offices that insist on a written record
of prior art, as in the United States. To this extent it would prevent cases of ‘biopiracy’. Around the time the TKDL was established in 2001, the TKDL expert group
estimated that, annually, some 2,000 patents relating to Indian medicinal systems
were being erroneously granted by patent offices around the world. TKDL thus
enables cancellation/withdrawal of wrong patent applications concerning India’s
traditional knowledge at zero cost and in few weeks time [12, 14].
CONCLUSIONS
Biopiracy is immerging scientific nuisance in pharmaceutical business. It can
commercialize locally as well as globally well known facts, inherited knowledge,
traditional knowledge, community wisdom, etc., in order to explore new opportunity
and cost saving in pharmaceuticals research and development. CBD and NAGOYA
protocol have tried to optimize the conflict between bio-pirates and original resources
bearers by proposing regulatory understanding which still needs to be revised and
redefined. In India, NBDA and TKDL are two start-up initiatives to counter act the
biopiracy.
REFERENCES
1. WIPO.
(2013)
Traditional
Knowledge,
Available
online:
http://www.wipo.int/tk/en/tk/ (updated: August 2013).
2. Sahay S, Pavithran P, Barpujari I: “Biopiracy: Imitations Not Innovations”,
Gene Campaign Publication, New Delhi, 2007.
3. Understanding, resisting and acting against biopiracy. Available online at
http://www.biopiraterie.org/sites/default/files/etudes/Livret_Uk_010612.pdf
(accessed September, 2013) The (French) Biopiracy Collective.
4. Stiglitz JE: “Globalization and its discontents”, W.W. Norton & Company,
New York, 2002.
5. Chouhan VK. (2012) Protection of Traditional Knowledge in India by Patent:
Legal Aspect. IOSR Journal of Humanities and Social Science. 3(1): 35-42.
6. Mgbeoji I: “Global Biopiracy: Patents, Plants and Indigenous Knowledge”,
Cornell University Press, Ithaca, 2006. Pp. 312.
7. Kurien K, Das A. (2011) Nagoya Protocol and Its Implications on
Pharmaceutical Industry. Beroe Inc. Publication, pp. 3-6.
8. Zakrzewski PA. (2002) Bioprospecting or Biopiracy? The Pharmaceutical
Industry’s Use of Indigenous Medicinal Plants as a Source of Potential Drug
Candidates. Compl. Alternat. Med. 79(3): 252-254
9. http://www.cbd.int/convention/text
10. http://www.nbaindia.org
11. ENVIS Newsletter. (2011) Envis Centre on Biotechnology, Vol. 19,
Department of Environmental Science, University of Kalyani, Nadia, West
Bengal.
12. Udgaonkar S. (2002) The recording of traditional knowledge: Will it prevent
‘bio-piracy’? Current Sci. 82(4): 413-419.
13. India and the WTO newsletter. (2004) Ministry of Commerce & Industry,
Government of India publication, Udyog Bhawan, New Delhi, 4(4): 7-19.
14. Gupta VK. (2011) Protecting India’s Traditional Knowledge. WIPO
Magazine, Available online: http://www.wipo.int/wipo_magazine/en/2011/03/
article_0002.html (updated: June 2011).